510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123937Substantially Equivalent

Atom Transcapsule V-707

Atom Medical Corporation, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123937 is the FDA 510(k) clearance record for ATOM TRANSCAPSULE V-707, a class II device, cleared for Atom Medical Corporation on under FDA product code FPL (Incubator, Neonatal Transport). FDA records list 15 510(k) clearances for Atom Medical Corporation, from to . As of , FDA records show no recalls naming K123937.

Clearance record

Decision date
Received
(154 days to decision)
Product code
FPL Incubator, Neonatal Transport
Regulation
21 CFR 880.5410
Device class
Class II
Review panel
General Hospital
Applicant
Atom Medical Corporation 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPL

Trailing 12 months

FDA records hold no clearances under product code FPL in the trailing twelve months.

FDA records show no clearances under product code FPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260